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Sinmed
EUDAMEDClass IIa (EU MDR)
Ref RHU-2019AHModel Type A, Type H, Type PA, Type PH
Identity
- Trade Name
- SINMED EUDAMED
- Device Name
- Regular Huber Needles EUDAMED
- Model / Reference
- Type A, Type H, Type PA, Type PH EUDAMEDRHU-2019AH EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975965297458 EUDAMED06978111922365 EUDAMED
- Basic UDI-DI
- 697122740RHUR4 EUDAMED
- Unit of Use DI
- 86975965297454 EUDAMED86978111922361 EUDAMED
- EMDN Code
- A01010302 NEEDLES AND KITS FOR IMPLANTABLE SYSTEMS (PORT), W/O SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Sinmed by Promisemed Hangzhou Meditech Co., Ltd. — Class IIa — CE/MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697122740RHUR4 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Promisemed Hangzhou Meditech Co., Ltd.
- EUDAMED SRN
- CN-MF-000008465
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 194043ee-ad28-4157-8c09-ef087e418651 61 fields · synced Oct 7, 2026
- EUDAMED 6774ed2f-9ef7-4f24-82cb-5254f105a0e6 61 fields · synced May 18, 2026